Safety Preservation of Medical Device "Accompanying Documents"(JIRA Topics)

A Medical Device Safety Supervision over Wireless

Interoperability of medical devices is a growing need in modern healthcare systems, not just for convenience, but also to preclude potential human errors during medical procedures. Caregivers, as end users, strongly prefer the use of wireless networks for such interconnections between clinical devices due to its seamless connectivity and ease of use/maintenance. In [KSM10], we introduced a Netw...

Using informatics to improve medical device safety and systems thinking.

The infusion pump informatics (IPI) system represents an innovative collaboration among a community of practice and researchers at Purdue University; the Rosen Center for Advanced Computing (RCAC) and the Regenstrief Center for Healthcare Engineering (RCHE). This six-year-old decision support system was started to address needs for better management of smart infusion pumps. IPI supports a syste...

Confronting systemic challenges in interoperable medical device safety, security & usability

Safety and security are negative goals. Safety, security and usability (SSU) are system properties. They cannot be isolated to a component or some layer of the system. All three are prerequisites for system effectiveness. Ensuring SSU of an integrated system requires a holistic view; a myopic view will mislead. Consider the following illustration of a cybersecurity breach among high profile ind...

Safety-Critical Medical Device Development Using the UPP2SF Model

Software-based control of life-critical embedded systems has become increasingly complex, and to a large extent has come to determine the safety of the human being. For example, implantable cardiac pacemakers have over 80,000 lines of code which are responsible for maintaining the heart within safe operating limits. As firmware-related recalls accounted for over 41% of the 600,000 devices recal...

Topics in medical economics: medical malpractice.